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    Summary
    EudraCT Number:2017-004125-32
    Sponsor's Protocol Code Number:APOCT-004
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-004125-32
    A.3Full title of the trial
    A randomised, double blind, placebo controlled trial to evaluate the safety, efficacy and pharmakokinetics of Pleconaril as an add on to AchEI/memantine for treatment of patients with Alzheimer’s disease
    Randomizowane, prowadzone metodą podwójnie ślepej próby, kontrolowane placebo badanie mające na celu dokonanie oceny bezpieczeństwa, skuteczności i farmakokinetyki plekonarylu dodanego do leczenia AChEI/memantyną pacjentów z chorobą Alzheimera
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, double blind, placebo controlled trial to evaluate the safety, efficacy and pharmakokinetics of Pleconaril as an add on to AchEI/memantine for treatment of patients with Alzheimer’s disease
    Randomizowane, prowadzone metodą podwójnie ślepej próby, kontrolowane placebo badanie mające na celu dokonanie oceny bezpieczeństwa, skuteczności i farmakokinetyki plekonarylu dodanego do leczenia AChEI/memantyną pacjentów z chorobą Alzheimera
    A.4.1Sponsor's protocol code numberAPOCT-004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorApodemus Aktiebolag
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportApodemus AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApodemus Aktiebolag
    B.5.2Functional name of contact pointClinical trials
    B.5.3 Address:
    B.5.3.1Street AddressNobels väg 3
    B.5.3.2Town/ citySolna
    B.5.3.3Post code171 65
    B.5.3.4CountrySweden
    B.5.6E-mailnina.lindblom@apodemus.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namepleconaril
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPLECONARIL
    D.3.9.1CAS number 153168-05-9
    D.3.9.2Current sponsor codeAPO-P001
    D.3.9.4EV Substance CodeSUB09957MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's disease
    E.1.1.1Medical condition in easily understood language
    Alzheimer's disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of Pleconaril on disease progression of Alzheimer’s Disease (AD) as assessed by the cognitive test Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog) compared to placebo from baseline to 12 months (Visit 7)
    E.2.2Secondary objectives of the trial
    Secondary objectives

    To investigate:
    - the effect of Pleconaril on disease progression of AD assessed by the cognitive test – ADAS-cog, and the cognitive and functional test - Clinical Dementia Rating (CDR) compared to placebo from baseline to 3, 6, 9 and 18 months for ADAS-cog and 9, 12 and 18 months for CDR
    - the effect of Pleconaril on the number of patients with a clinically relevant change compared to placebo at 6, 9 and 12 months and at 10 weeks and 6 months follow up
    - the effect of Pleconaril on the disease progression of AD as assessed by the cognitive test - ADAS-cog and the cognitive and functional test - CDR after end of treatment with Pleconaril compared to baseline and 12 month visit respectively compared to placebo
    - the safety and tolerability of Pleconaril in patients with AD compared to placebo
    - the pharmacokinetics of Pleconaril in plasma from patients with AD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female patients diagnosed with AD according to ICD-10
    2) Age 60 to 85 years (inclusive) at the time of informed consent
    3) Patient has stable AChEI and/or memantine for dementia (stable treatment is defined as stable in type of treatment and dose for at least 3 months prior to the baseline visit)
    4) MMSE score 20 to 27 (inclusive) and judged by the Investigator to be able to give informed consent
    5) Patients have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol, as judged by the Investigator
    6) 12-lead ECG with normal tracings; or changes that are not clinically significant and do not require medical intervention, as judged by the Investigator
    7) Patient has a relative or caregiver, judged as reliable by the Investigator, who has signed informed consent.
    The relative or caregiver should participate in the patient’s visits at the clinic and assist the patient with drug compliance at home.
    8) Willingness to participate after signing informed consent
    E.4Principal exclusion criteria
    1) Active hepatitis B, active hepatitis C, or HIV infection
    2) Serious cardiac disease including unstable or uncontrolled cardiac disease during the last 6 months and/or previous history of deep vein thrombosis or clinical signs of deep venous thrombosis
    3) Major psychiatric disorder (e.g. schizophrenia or past or present major depression disorder or as judged by the investigator)
    4) Major surgical procedure within 4 weeks prior to inclusion
    5) Women of childbearing potential (WOCBP) without reliable contraceptive method.
    For the purpose of this trial, WOCBP includes any female who had experienced menarche, who had not undergone tubal ligation, and who is not postmenopausal. Post menopause was defined as amenorrhea ≥ 12 consecutive months without another cause.
    6) Previous stroke
    7) Unstable treatment with Vitamin B12 medication, thyroid disorder medication, TNF-alpha blocking agents, antidepressants, cholinergic drugs, other AD medications (e.g. souvenaid)
    Unstable treatment is defined as unstable in type of treatment and dose in the 3 months prior to the baseline visit. (Therefore, all patients not requiring such treatment or with stable treatment may be included)
    8) Participation in any other clinical trial within 30 days of inclusion (randomisation) in the trial or patients with unresolved investigational treatment-related adverse events
    9) Other chronic disease or previous organ transplantation judged by the Investigator to interfere with the assessment of treatment success and/or ability to fully participate in the trial
    10) Patients that require immunosuppressive treatments including azathioprine, ciclosporin, systemic steroid treatment (e.g. prednisolone at doses of ≥10 mg/day or hydrocortisone) or has received such treatment within the last 6 months prior to randomization
    11) Patients that are treated with drugs that can interact significantly with Pleconaril; ethinylestradiol
    12) Lack of suitability for participation in the trial, for any reason, as judged by the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    Change in ADAS-cog total score from baseline to 12 months (Visit 7)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    The efficacy endpoints are:
    Change in disease progression of AD as assessed by:
    - Change in ADAS-cog total score from baseline to 3 months (Visit 4), 6 months (Visit 5), 9 months (Visit 6), the 10 week follow up (Visit 8) and 6 month follow-up visit (Visit 9)
    - Change in CDR-sb from baseline to 9 months (Visit 6), 12 months (Visit 7) and 6 month follow-up visit (Visit 9)
    - Difference between groups in number of patients with a clinically relevant improvement and a clinically relevant worsening in ADAS-cog total score at 6 months (Visit 5), 9 months (Visit 6), 12 months (Visit 7) and at the 10 week and 6 month follow-up visits (visits 8 and 9). A clinically relevant improvement is defined as a decrease in ADAS-cog total score of at least 4 points compared to baseline and a clinically relevant worsening is defined as an increase in ADAS-cog total score of at least 4 points compared to baseline.
    - Change in ADAS-cog total score from 12 months (Visit 7) (end of treatment) to the 10 week and 6 month follow-up visits (visits 8 and 9)
    - Change in CDR-sb from 12 months (Visit 7) (end of treatment) to the 6 month follow-up visit (Visit 9)

    The safety endpoints are:
    - Frequency and intensity of AEs
    - Tolerability, as assessed by dose interruption (at least 5 consecutive days)- or discontinuation of Pleconaril /placebo
    - Changes in vital signs
    - Changes in laboratory parameters
    - Changes in physical examination
    - Signs of muscle inflammation and thrombosis
    - Changes in ECG
    - Changes in Weight

    The pharmacokinetic endpoints are:
    - Change of accumulation, as determined by trough concentrations (all patients)
    - Cmax following first daily dose on the first and last day of dosing (extended PK group)
    - Accumulation ratios, calculated from AUC(0-24) and Cmax, following the first daily dose on the first and last day of dosing (extended PK group)
    - If possible, apparent clearance (CL/F) and apparent volume of distribution (V/F), as determined by a model based approach (all patients)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy endpoints: see E.5.2
    Safety endpoints: throughout the study
    Pharmacokinetic endpoints: baseline, 12 months, Follow-up 6-months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No treatment will be provided to the patients after the end of the trial
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-03-02
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